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Islet Transplant in Patients With Type I Diabetes

NCT03698396 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-30

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the safety of allogenic islet transplantation in type 1 diabetic patients performed at the University of Virginia.

The purpose is to demonstrate that islet transplantation can be performed safely and reliably achieves better glycemic control than state-of-the-art insulin treatment in management of type 1 diabetic patients with brittle control and a history of severe hypoglycemic episodes with hypoglycemia unawareness.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Allogenic Islet Cell Transplantation

Transplantation of allogenic islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.

Sponsors & Collaborators

  • Kenneth Brayman, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-11-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698396 on ClinicalTrials.gov